Guidance for the Clinical Trials Evaluation for Hypertension

고혈압치료제의 임상시험평가지침 연구

  • Park, Hyun-Joo (Clinical Research Division, Toxicological Evaluation and Research Department, National Institute Food and Drug Safety Evaluation) ;
  • Oh, Woo-Yong (Oncology and Antibiotics Division, Korea Food and Drug Administration) ;
  • Na, Han-Sung (Clinical Research Division, Toxicological Evaluation and Research Department, National Institute Food and Drug Safety Evaluation) ;
  • Han, Soon-Young (Clinical Research Division, Toxicological Evaluation and Research Department, National Institute Food and Drug Safety Evaluation) ;
  • Choi, Ki-Hwan (Cardiovascular and Neuropharmacology Drug Division, Korea Food and Drug Administration) ;
  • Ko, Yong-Suk (Cardiovascular and Neuropharmacology Drug Division, Korea Food and Drug Administration) ;
  • Wang, So-Young (Cardiovascular and Neuropharmacology Drug Division, Korea Food and Drug Administration) ;
  • Chung, Myeon-Woo (Clinical Research Division, Toxicological Evaluation and Research Department, National Institute Food and Drug Safety Evaluation)
  • 박현주 (식품의약품안전평가원 임상연구과) ;
  • 오우용 (식품의약품안전청 종양약품과) ;
  • 나한성 (식품의약품안전평가원 임상연구과) ;
  • 한순영 (식품의약품안전평가원 임상연구과) ;
  • 최기환 (식품의약품안전청 순환계약품과) ;
  • 고용석 (식품의약품안전청 순환계약품과) ;
  • 왕소영 (식품의약품안전청 순환계약품과) ;
  • 정면우 (식품의약품안전평가원 임상연구과)
  • Received : 2009.10.14
  • Accepted : 2009.12.17
  • Published : 2009.12.30

Abstract

Keywords

References

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  2. Note for Guidance on Clinical Investigation of Medicinal Products in the Treatment of Hypertension. EMEA 2004. Available from: http://www.emea.europa.eu/pdfs/human/ewp/023895en.pdf
  3. Concept Paper on the Need for Regulatory Guidance in the Evaluation of Medicinal Products for a First-Line Indication of Fixed Combination Medicinal Products in Therapeutic Doses in the Treatment of Hypertension. EMEA 2006. Available from: http://www.emea.europa.eu/pdfs/human/ewp/42609306en.pdf
  4. Chobanian AV, et al. Seventh report of the Joint National Committee on Prevention, Detection, and Treatment of High Blood Pressure. Hypertension 2003;42:1206-52. https://doi.org/10.1161/01.HYP.0000107251.49515.c2
  5. Guideline Committee. 2007 European Society of Hypertension-European Society of cardiology guideline for the management of arterial hypertension (Journal of hypertension 2007, 25:1751-1762) https://doi.org/10.1097/HJH.0b013e3282f0580f
  6. Guidelines Sub-Committee. 1999 World Health Organization-International Society of Hypertension guidelines for the management of hypertension. J Hypertens 1999;17:151-83.
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  9. 혈압 모니터 지침 (대한고혈압학회, 2007년)
  10. Guideline on the evaluation of medical products for cardiovascular disease prevention (EMEA guideline, 2007)
  11. 고혈압치료제의 임상시험평가지침 (식품의약품안전청, 2009)